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Trial registered on ANZCTR


Registration number
ACTRN12620001378910
Ethics application status
Approved
Date submitted
28/08/2020
Date registered
22/12/2020
Date last updated
19/11/2021
Date data sharing statement initially provided
22/12/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
RoLaCaRT-1: A Randomized Trial of Robotic Surgery versus Laparoscopic Surgery for Colon Cancer
Scientific title
RoLaCaRT-1: An international randomised phase II trial comparing surgical outcomes of robotic-assisted right hemicolectomy versus laparoscopic-assisted hemicolectomy for resection of adenocarcinoma of the caecum, ascending or proximal transverse colon
Secondary ID [1] 302111 0
CTC 0270 / AG0119CS
Universal Trial Number (UTN)
Trial acronym
RoLaCaRT-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adenocarcinoma (tumour or malignant polyp) of the caecum, ascending or proximal transverse colon. 318737 0
Condition category
Condition code
Cancer 316753 316753 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Surgeon will perform Right hemicolectomy performed by a robotic surgery using the da Vinci Xi surgical robotic
A robotic right hemicolectomy is performed with the da VINCI Xi surgical robot using up to four robotic arms to control small instruments introduced into the abdomen through 3 – 6 small incisions on the abdomen measuring around 8mm. One robotic arm is used for a camera. The tumour is removed through another incision (about 5cm to 8cm). The approximate duration of surgery is two hours. Surgeons will be required to electronically record every operation they perform in this study.
Intervention code [1] 318412 0
Treatment: Surgery
Comparator / control treatment
Right hemicolectomy performed by laparoscopic surgery
A laparoscopic right hemicolectomy is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 to 6 positions on the abdomen through 3 – 6 small incisions measuring 5 to 10 mm, under the guidance of a video camera. The tumour is removed through another incision (about 5cm to 8cm). The approximate duration of surgery is two hours. Surgeons will be required to electronically record every operation they perform in this study.
Control group
Active

Outcomes
Primary outcome [1] 324880 0
To determine if performing right hemicolectomy robotically compared with laparoscopic hemicolectomy in patients with adenocarcinoma of the caecum, ascending or proximal transverse colon improves surgical morbidity.
Surgical morbidity/mortality up to 90 days (as measured by Clavien-Dindo and the Comprehensive Complication Index).
.
Timepoint [1] 324880 0
90 days post-surgery.
Secondary outcome [1] 386087 0
Pathological quality assessment.The completeness of mesocolon excision (CME) according to Benz classification:
o Anatomical completeness of the mesocolon (Type 0–III)
o Three subcategories (A,B,C) for integrity of the mesocolon
o Distal resected margin equal to or greater than 5cm
o Lymph node yield
o Mesocolic plane of surgery
o R0 resection (all margins clear)
This outcome is assessed using information detailed in the patient's medical records and pathology report.
Timepoint [1] 386087 0
Immediate post-operative period
Secondary outcome [2] 386213 0
Successful surgical episode of care which be deemed to have been achieved only if all eight (8) of the following binary outcomes are obtained.
a. No ileus or insertion of nasogastric tube (NGT) (defined as ‘tolerating diet’ by Day 2).
b. No anastomotic complication (leak, haemorrhage, stenosis requiring reoperation, endoscopic intervention or transfusion).
c. No surgical site infection (at specimen extraction site).
d. No prolonged hospital stay or unplanned readmission (>1.5 SD above the mean, adjusted for each geographical region) (after day of surgery).
e. No wound hernia at 12 months (patient reported or clinical examination, ultrasound or CT).
f. No conversion or change in operative approach to otherwise achieve the final goal (defined as inability to complete the dissection, including the vascular ligation and/or requiring an incision larger than that required to remove the specimen, or perform extracorporeal anastomosis) i.e. laparoscopic-assisted technique to a robotic or hand-assisted or hybrid procedure, robotic-assisted technique to a laparoscopic or hand-assisted or hybrid procedure, or any conversion to an open procedure. If a planned intracorporeal anastomosis is not completely performed in an intracorporeal approach, the case is considered also to have been converted.
g. No other significant post-operative complication, including DVT/PE, acute renal failure, cardiac or respiratory complications (Clavien-Dindo grades III or higher).
h. Pathologically clear resection margins (R0).
As per patients medical records
Timepoint [2] 386213 0
a: Day two post-operative period
b; c; d: within 90 days post-operative period
e: within 12 months post-operative period
f: at time of surgery
g: post-operatively to 90 days
h: Immediate post-operative period
Secondary outcome [3] 386214 0
Validation of the concept of ‘successful surgery’ by correlation with the Comprehensive Complication Index
The Comprehensive Complication Index is a Tool used to measure, also information taken from patient medical records, .
Timepoint [3] 386214 0
At 12 months post procedure
Secondary outcome [4] 386215 0
Quality of Life EORTC measured by QLQ-C30, QLQ-CR29, EQ-5D-5L patient reported outcomes
Timepoint [4] 386215 0
At Baseline , post-operative at discharge , 1, 3, 6 and 12 months post-surgery
Secondary outcome [5] 386216 0
Pain evaluation assessed by the Brief Pain Inventory (BPI)
Timepoint [5] 386216 0
Post-operative on days one, three and five.
Secondary outcome [6] 386217 0
Time to return to work or unpaid activity using the Labour Force survey.
Timepoint [6] 386217 0
At baseline, post-operative at 30 days and 3 months post-surgery
Secondary outcome [7] 386218 0
Ventral hernia at laparotomy or specimen extraction site will be assessed by CT abdomen or ultrasound during routine follow up schedule
Timepoint [7] 386218 0
At 12 and 24 months post-procedure
Secondary outcome [8] 386219 0
Operator cognitive load assessment using the NASA Task Load Index (TLX) for score of technical difficulty, completed by surgeon.
Timepoint [8] 386219 0
Immediate post-operative period
Secondary outcome [9] 386220 0
Assessment of intraoperative adverse events within advanced minimally-invasive surgery in order to report ‘near misses’ and associated impact upon clinical outcomes. Surgical procedure will be reviewed by the Surgical Assessment Committee (SAC) using NCI CTC AE 5.0/ Clavien-Dindo).


Timepoint [9] 386220 0
12 months post-procedure
Secondary outcome [10] 386221 0
Objective analysis of intraoperative surgical performance: surgical performance case video. Surgical procedure will be reviewed by the Surgical Assessment Committee (SAC) using OCHRA and L-CAT scoring matrices.
Timepoint [10] 386221 0
12 months post-procedure
Secondary outcome [11] 386222 0
Local disease recurrence-Tests Chest /Abdomen/ Pelvis CT Scan, Colonoscopy and clinical assessment
Timepoint [11] 386222 0
Two years post procedure
Secondary outcome [12] 386223 0
Disease free survival. Tests Chest /Abdomen/ Pelvis CT Scan, clinical assessment
Timepoint [12] 386223 0
Two and five years post procedure
Secondary outcome [13] 386224 0
Overall survival
Timepoint [13] 386224 0
Five and ten years post procedure
Secondary outcome [14] 386225 0
Cost-effectiveness from a health system and societal perspective.
While no formal cost effectiveness analysis is planned the participants in RoLaCaRT-1 will complete the EQ-5D-5L, Brief Pain Inventory (BPI), QLQ-C30 and Labour Force Participation survey and be asked for consent for release of personal Medicare and PBS claims. The required follow up and activities to assess cost effectiveness will be included within a planned extended study protocol (RoLaCaRT-2).
Timepoint [14] 386225 0
12 months post procedure

Eligibility
Key inclusion criteria
1. Adults with adenocarcinoma (tumour or malignant polyp) of the caecum, ascending or proximal transverse colon. Disease must be confirmed by histological, radiological, endoscopic diagnosis.
2. ECOG performance status 0-2.
3. Life expectancy of at least 1 year.
4. Surgery to be performed within 40 days of randomisation.
5. Elective surgery performed with curative intent.
6. Signed, written informed consent.
7. Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments.

Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Evidence of T4 disease invading adjacent organs.
2. Pre-operative surgical plan includes division of the middle colic vessels (extended right hemicolectomy) or any other more extensive colectomy procedure.
3. Synchronous surgical procedure planned with right hemicolectomy.
4. Urgent, unplanned or emergency surgery.
5. Palliative surgical intent including non-resection, stoma formation, staging laparoscopy or open and close procedures.
6. Prior formation of defunctioning ileostomy as part of treatment for this right colon cancer.
7. No plan to create a surgical ileo-colonic anastomosis.
8. Neoadjuvant chemotherapy administered to treat this cancer prior to resection.
9. Known Crohn’s disease with active terminal ileal disease.
10. History of any conditions that would preclude use of a minimally-invasive approach (e.g. multiple previous major laparotomies, severe adhesions, patient co-morbidity).
11. Concurrent or previous abdominal or pelvic malignancy within five years prior to registration irrespective of treatment modality.
12. Other co-morbidities or conditions that may compromise assessment of key outcomes.
13. Significant metastatic disease which would be expected to impact life expectancy of at least 1 year
14. Evidence of systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude surgery, or other severe incapacitating disease, i.e. ASA IV (a patient with severe systemic disease that is a constant threat to life) or ASA V (a moribund patient who is not expected to survive without the operation).
15. Pregnancy or lactation.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Using the method of minimization and stratifying for gender, BMI (<30 v >30) tumour site (caecum/ascending colon v. hepatic flexure or proximal transverse colon) and surgeon, appropriate weights will be implemented in the minimisation algorithm in order to preserve the proposed 2:1 ratio favouring the experimental arm.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis
RoLaCaRT-1 has been designed as a 50 patient pilot study for the assessment of 90-day surgical morbidity/mortality, patient reported outcomes and study feasibility.
Analyses will be conducted according to the principle of intention to treat (ITT). Exploratory comparisons will comprise of tests for continuous and some categorical outcomes (e.g., positive margins). Descriptive statistics will be reported counts with percentages for categorical variables.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 21138 0
Sydney Adventist Hospital - Wahroonga
Recruitment hospital [2] 21139 0
Epworth Richmond - Richmond
Recruitment hospital [3] 21140 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [4] 21141 0
Prince of Wales Private Hospital - Randwick
Recruitment hospital [5] 21142 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [6] 21143 0
Cabrini Hospital - Malvern - Malvern
Recruitment hospital [7] 21144 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [8] 21145 0
Mater Private Hospital - South Brisbane
Recruitment postcode(s) [1] 35998 0
2076 - Wahroonga
Recruitment postcode(s) [2] 35999 0
3121 - Richmond
Recruitment postcode(s) [3] 36000 0
2050 - Camperdown
Recruitment postcode(s) [4] 36001 0
2031 - Randwick
Recruitment postcode(s) [5] 36002 0
3000 - Melbourne
Recruitment postcode(s) [6] 36003 0
3144 - Malvern
Recruitment postcode(s) [7] 36004 0
4029 - Herston
Recruitment postcode(s) [8] 36005 0
4101 - South Brisbane
Recruitment outside Australia
Country [1] 22896 0
United States of America
State/province [1] 22896 0
Mayo Clinic, Rochester Minnesota, Mayo Clinic, Jacksonville, Florida
Country [2] 22900 0
United Kingdom
State/province [2] 22900 0
Queen Alexandra Hospital, Portsmouth, St Marks Hospital, London

Funding & Sponsors
Funding source category [1] 306535 0
Commercial sector/Industry
Name [1] 306535 0
Intuitive Inc.
Address [1] 306535 0
1020 Kifer Road, Sunnyvale, CA 94086-5304 USA
Country [1] 306535 0
United States of America
Primary sponsor type
Other Collaborative groups
Name
Australasian Gastrointestinal Trials Group (AGITG)
Address
Level 6, 119 Missenden Rd, Camperdown,2050 NSW Australia.
Country
Australia
Secondary sponsor category [1] 307104 0
Hospital
Name [1] 307104 0
Mayo Clinic, Rochester, Minnesota
Address [1] 307104 0
200 1st St SW, Rochester, MN 55905, United States
Country [1] 307104 0
United States of America
Secondary sponsor category [2] 308152 0
Hospital
Name [2] 308152 0
Portsmouth Hospitals University NHS Trust
Address [2] 308152 0
Queen Alexandra Hospital, Cosham, Portsmouth, PO6 3LY
Country [2] 308152 0
United Kingdom
Other collaborator category [1] 281438 0
University
Name [1] 281438 0
University of Sydney
Address [1] 281438 0
NHMRC Clinical Trials Centre
Level 6, 119 Missenden Rd
Camperdown, NSW 2050
Sydney, Australia.
Country [1] 281438 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306731 0
Sydney Local Health District Ethics Review Committee (RPAH Zone
Ethics committee address [1] 306731 0
RESEARCH ETHICS AND GOVERNANCE OFFICE
ROYAL PRINCE ALFRED HOSPITAL
100 Carillon Ave, Newtown NSW 2042
CAMPERDOWN NSW 2050
Ethics committee country [1] 306731 0
Australia
Date submitted for ethics approval [1] 306731 0
11/12/2019
Approval date [1] 306731 0
12/05/2020
Ethics approval number [1] 306731 0
X19-0463

Summary
Brief summary
The aim of this study is to compare the use of robotic surgery with laparoscopic surgery for the surgical treatment of right sided colon cancer. Robotic and laparoscopic operations are called minimally invasive surgery, that is, they use instruments fitted in through small incisions or cuts in the abdomen. The removal of the colon cancer tumour called a hemicolectomy and in this study for right-sided colon cancer it is called a right hemicolectomy.

Who is it for?
You may be eligible to join this study if you are an adult aged 18 years and older, have adenocarcinoma (tumour or malignant polyp) of the caecum, ascending or proximal transverse colon that requires surgery. Disease must be confirmed by histological, radiological, endoscopic diagnosis

Study Details
Participants in this study will be randomly allocated (by chance) to either robotic or laparoscopic surgery. You will have a two to one chance of be allocated robotic surgery. The purpose of the study is to evaluate the surgery and it’s short and longer term outcomes, quality of life, cost effectiveness and surgeons’ experience with the robotic surgery approach. All participants will be monitored for up to 12 months for recovery from surgery, adverse events, quality of life and return to usual activities or work.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104826 0
Prof Andrew Stevenson
Address 104826 0
St Vincent's Private Hospital Northside
627 Rode Road
Chermside, Brisbane, Queensland 4032
Australia
Country 104826 0
Australia
Phone 104826 0
+61 07 3256 4504
Fax 104826 0
Email 104826 0
arl.stevenson@me.com
Contact person for public queries
Name 104827 0
Ms Kate Wilson
Address 104827 0
NHMRC Clinical Trials Centre
Levels 4-6 Medical Foundation Building,
92-94 Parramatta Rd, Camperdown NSW 2050
Country 104827 0
Australia
Phone 104827 0
+61 2 9562 5000
Fax 104827 0
Email 104827 0
RoLaCaRT@ctc.usyd.edu.au
Contact person for scientific queries
Name 104828 0
Prof Andrew Stevenson
Address 104828 0
St Vincent's Private Hospital Northside
627 Rode Road
CHERMSIDE QLD 4032
Country 104828 0
Australia
Phone 104828 0
+61 073256 4504
Fax 104828 0
Email 104828 0
RoLaCaRT@ctc.usyd.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results